Gemin X initiates Phase II lung cancer trial

In this multi-center, randomized, open-label Phase II study, clinical effect of a combination of carboplatin, etoposide and obatoclax will be compared to the standard chemotherapeutic therapy of carboplatin and etoposide alone (the control arm) in patients with small cell lung cancer (SCLC).

The primary endpoint of the study, expected to enroll approximately 150 patients with SCLC, is comparison of overall response rate for the obatoclax-containing arm versus the control arm. Secondary endpoints include comparison of progression free survival and overall survival, as well as safety.

The ongoing Phase Ib dose-escalation portion of this study established safety and identified the recommended dose for obatoclax, when administered in combination with standard doses of carboplatin and etoposide as both front-line and second-line therapy, the company said. This Phase Ib trial showed a significant response rate for the SCLC patients dosed with the obatoclax-chemotherapy combination after two cycles of therapy, based on RECIST measures.

In the Phase II study, each patient in the obatoclax combination arm will receive three-hour infusions on three consecutive days of dosing every three weeks over six treatment cycles. Patients enrolled into the obatoclax combination arm of the study and who have not progressed after six treatment cycles will continue to receive obatoclax alone as maintenance therapy after completion of combination chemotherapy. The trial is expected to be completed by the fourth quarter of 2009.

Glenn Gormley, president and CEO of Gemin X, said: “We are very pleased to begin this Phase II study in SCLC in accordance with our broad development plan for obatoclax, which also includes Phase II trial initiations this year in acute lymphoblastic leukemia and systemic mastocytosis.”